The History of Informed Consent

There is a long history to the subject of Informed Consent. At first, regulation of the medical community focused on the rights of those who participated in medical research more than those who were receiving medical treatment. Yet, from this work on regulating the rights of patients involved in research, the medical community did gradually put attention on informed consent as a right of the patient for any and all medical treatment.

Throughout the country, there are different rules and regulations state-to-state, regarding consent. To date, there is not a federal bill or law that has passed that defines informed consent.
One of the first, global discussions of patients’ rights was initiated in 1947 at the trial of Nazi war criminals for the unethical use of subjects in cruel, tortuous, and life-threatening experiments. These trials led to the formulation of the Nuremberg Code. This Code establishes that the individual should “have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.” [1]

In 1964, the Ethical Principles for Medical Research Involving Human Subjects was Adopted in June 1964. [2] These principles were a launching point for the language we now know as Informed Consent. All of these historical documents are helpful in establishing a reference point for any and all individuals, no matter which state you live in, for what is informed consent.

By 1981, the Department of Health and Human Services and the Food and Drug Administration issued regulations based on the Belmont Report (an earlier report on ethical guidelines). These regulations furthered the concept of consent for those involved in research. [3] Among some of the concepts were, that an individual has the right to “an explanation and purposes” of the research, “foreseeable risks or discomforts”, “any benefits” and a “disclosure of appropriate alternative procedures or courses of treatment”.

In 1962, after 8000 babies were born deformed due to their mothers having taken a sleeping-pill-tranquilizer called “thalidomide”, a Consumer Bill of Rights was proclaimed. This rights declaration included the right to safety, the right to be informed, the right to choose and the right to be heard. [4]

The 1966 Fair Packaging and Labeling Act required all consumer products in interstate commerce, including drugs and medical devices, to be informatively labeled. [5] In 1970 FDA directed manufacturers to include package inserts for patients describing risks and benefits of oral contraceptives. Written information sheets soon began to accompany both prescription and nonprescription medications.

One court case, Cruzan by Cruzan v. Director, led by the State Supreme Court in Missouri, recognized “a right to refuse treatment”. [6] This case and others helped to further refine the concept of informed consent. Today, informed consent is a fundamental right of the patient.

In the state of Florida, there is a Patient Bill of Rights, under the Division of Medical Quality Assurance, Department of Health. Within that Bill of Rights, you will find the right to information. It is defined as follows:

“A patient has the right to be given by his or her health care provider information concerning diagnosis, planned course of treatment, alternatives, risks, and prognosis, unless it is medically inadvisable or impossible to give this information to the patient, in which case the information must be given to the patient's guardian or a person designated as the patient's representative. A patient has the right to refuse this information.

A patient has the right to refuse any treatment based on information required by this paragraph, except as otherwise provided by law. The responsible provider shall document any such refusal.” [7]

In addition to this Bill of Rights, is the Florida Statute 39.407, which addresses consent to medical treatment for children under state care.

“Consent to medical treatment shall be obtained from a parent or legal custodian of the child” or “A court order for such treatment shall be obtained.

‘Express and informed consent’ means consent voluntarily given in writing, by a competent person, after sufficient explanation and disclosure of the subject matter involved to enable the person to make a knowing and willful decision without any element of force, fraud, deceit, duress, or other form of constraint or coercion.” [8]

Per Florida Statute 394.459(3)(a), which is a statute that is for all Floridians, not just those under state care, “the following information shall be provided and explained in plain language to the patient, or to the patient's guardian… the reason for admission or treatment; the proposed treatment; the purpose of the treatment to be provided; the common risks, benefits, and side effects thereof; the specific dosage range for the medication, when applicable; alternative treatment modalities; the approximate length of care; the potential effects of stopping treatment; how treatment will be monitored; and that any consent given for treatment may be revoked orally or in writing before or during the treatment period by the patient or by a person who is legally authorized to make health care decisions on behalf of the patient.” [9]

Go to www.cchrflorida.org/ to get your copy of the Patient Bill of Rights for Florida. If you are out of state, you can search online to find the regulations and statutes that are specific for your state.

If you, or a family member or friend, are concerned about your rights in the field of mental health, you have the right to demand Express and Informed Consent.

1. Nuremberg Code. http://ohsr.od.nih.gov/guidelines/nuremberg.html
2. Ethical Principles for Medical Research Involving Human Subjects http://ohsr.od.nih.gov/guidelines/helsinki.html
3. Code of Federal Regulations http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116; and
FDA issued regulations based on the Belmont Report http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showFR=1
4. Consumer Bill of Rights http://www.hcqualitycommission.gov/cborr/chap4.html
5. 1966 Fair Packaging and Labeling Act http://www.ftc.gov/os/statutes/fpla/fplact.html
6. Court case Cruzan by Cruzan v. Director http://www4.law.cornell.edu/supct/html/historics/USSC_CR_0497_0261_ZS.html

7. Patient Bill of Rights http://www.doh.state.fl.us/mqa/Profiling/billofrights.htm

8. Florida Statute 39.407
http://www.leg.state.fl.us/statutes/index.cfm?App_mode=Display_Statute&
Search_String=&URL=Ch0039/Sec407.htm

9. Florida Statute 394.459(3)(a)
http://www.leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&
Search_String=&URL=Ch0394/Sec459.HTM